Mebeverine
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Clinical Pharmacology
Sparex - myotropic antispasmodic action, has a direct effect on the smooth muscles of the gastrointestinal tract (mainly the large intestine). Eliminates spasm without affecting the normal intestinal motility. Inhibits phosphodiesterase. Stabilizes the level of cyclic adenosine monophosphoric acid. Does not possess anticholinergic action.
Indications
In adults
Spasm of the gastrointestinal tract (including caused by an organic disease), intestinal colic, biliary colic, irritable bowel syndrome.
In children older than 12 years
Functional disorders of the gastrointestinal tract, accompanied by abdominal pain.
Composition
Active substance: Mebeverinee hydrochloride 200 mg;
Excipients: colloidal silicon dioxide (Aerosil), hypromellose (hydroxypropylmethylcellulose brand Benecel MP 874), povidone (plasdone K 90, kollidon 90 F), magnesium stearate
Mebeverine is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Sparex | Canonpharma | Russia | capsules |
Niaspam | Sun Pharmaceutical Industries Ltd | India | capsules |
Duspatalin | Abbott | USA | pills |
Duspatalin | Abbott | USA | capsules |
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Dosage and Administration
For oral administration.
Capsules need to be swallowed, drinking plenty of water (at least 100 ml). Capsules should not be chewed, since their shell provides a long-term release of the drug.
Take one capsule 2 times a day 20 minutes before meals, one capsule in the morning and one capsule in the evening.
The duration of the drug is not limited.
If the patient has forgotten to take one or more doses, the drug should be continued with the next dose. One or more missed doses should not be taken in addition to the usual dose.
Use in special patient groups
Dose adjustment is not required for elderly patients, patients with hepatic and / or renal insufficiency.
Adverse reactions
The reported side effects were spontaneous and there is not enough data available to accurately estimate the frequency of cases.
Allergic reactions were observed mainly on the part of the skin, but other manifestations of allergy were also noted.
On the part of the skin and subcutaneous tissues: urticaria, angioedema, including the face, exanthema.
On the part of the immune system: hypersensitivity reactions (anaphylactic reactions).
Contraindications
Hypersensitivity to any component of the drug.
Age up to 18 years (due to the lack of data on efficacy and safety).
Pregnancy (due to lack of data), breastfeeding period.
Drug interactions
Conducted only studies on the interaction of Mebeverine with ethanol. Animal studies have demonstrated the absence of any interaction between Mebeverine and ethanol.
Pregnancy and Lactation
Pregnancy
There are only very limited data on the use of Mebeverine in pregnant women. The drug is not recommended for use during pregnancy.
Breastfeeding period
Information on the excretion of Mebeverine or its metabolites in breast milk is not enough. Do not take the drug during breastfeeding.
Fertility
Clinical data on the effect of the drug on fertility in men or women are not available, however, animal studies have not demonstrated adverse effects of the drug.
Special instructions
Influence on ability to drive motor transport and control mechanisms
Niaspam does not affect the ability to drive and engage in potentially hazardous activities that require increased concentration and psychomotor speed.
Overdosage
Symptoms: theoretically, in case of an overdose, the excitability of the central nervous system may increase. In cases of overdose of Mebeverine, the symptoms were either absent or insignificant and, as a rule, quickly reversible. The observed symptoms of overdose were neurological and cardiovascular.
Treatment: symptomatic treatment is recommended. Gastric lavage is necessary only if intoxication is detected within approximately one hour after taking several doses of the drug. Absorption reduction measures are not required. The specific antidote is unknown.
- Active ingredient: Mebeverine
Studies and clinical trials of Mebeverine (Click to expand)
- A validated chiral HPLC method for the determination of mebeverine HCl enantiomers in pharmaceutical dosage forms and spiked rat plasma
- Evaluation of capillary supercritical fluid chromatography with mass spectrometric detection for the analysis of a drug (mebeverine) in a dog plasma matrix
- Determination of two mebeverine metabolites, mebeverine alcohol and desmethylmebeverine alcohol, in human plasma by a dual stable isotope-based gas chromatographic-mass spectrometric method
- Development and validation of stability indicating HPLC and HPTLC methods for determination of sulpiride and mebeverine hydrochloride in combination
- Potentiometric flow injection analysis of mebeverine hydrochloride in serum and urine
- Spectrophotometric determination of benzydamine HCl, levamisole HCl and mebeverine HCl through ion-pair complex formation with methyl orange
- Quantitative determination of mebeverine HCl by NMR chemical shift migration
- Reversed-phase high-performance thin-layer chromatography of mebeverine hydrochlordie and related compounds
- Development of a standardized analysis strategy for basic drugs using ion-pair extraction and high-performance liquid chromatography : VIII. Method construction for the determination of mebeverine in tablets and biological fluids
- Identification of mebeverine acid as the main circulating metabolite of mebeverine in man
- Application of first-derivative UV-spectrophotometry, TLC-densitometry and liquid chromatography for the simultaneous determination of mebeverine hydrochloride and sulpiride
- Mebeverine alters small bowel motility in irritable bowel syndrome
- Mebeverine decreases mass movements and stool frequency in lactulose-induced diarrhoea
- Alosetron relieves pain and improves bowel function compared with mebeverine in female nonconstipated irritable bowel syndrome patients
- Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial)
- Treatment patterns and health care costs of mebeverine-treated IBS patients: a case-control study
- Spectrophotometric determination of mebeverine hydrochloride
- Quantitative analysis of mebeverine in dosage forms by HPLC
- Lack of bioavailability of mebeverine even after pretreatment with pyridostigmine
- First Derivative Synchronous Fluorescence Spectroscopy for the Simultaneous Determination of Sulpiride and Mebeverine Hydrochloride in Their Combined Tablets and Application to Real Human Plasma
- Process, optimization and characterization of mebeverine hydrochloride loaded guar gum microspheres for irritable bowel syndrome
- Quantitative HPLC analysis of mebeverine, mesalazine, sulphasalazine and dispersible aspirin stored in a Venalink monitored dosage system with co-prescribed medicines
- Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine
- Design and Formulation of Mebeverine HCl Semisolid Formulations for Intraorally Administration